SPRAVATO

Krajina: Indonézia

Jazyk: indonézština

Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktívna zložka:

ESKETAMINE HYDROCHLORIDE

Dostupné z:

INTEGRATED HEALTHCARE INDONESIA - Indonesia

INN (Medzinárodný Name):

ESKETAMINE HYDROCHLORIDE

Dávkovanie:

37.1 Mg

Forma lieku:

NASAL SPRAY

Počet v balení:

BOX, 1 BLISTER @ 1 PRE-FILLED NASAL SPRAY DEVICE

Výrobca:

RENAISSANCE LAKEWOOD LLC - United States of America

Dátum Autorizácia:

2021-04-23

Súhrn charakteristických

1.
NAME OF THE MEDICINAL PRODUCT
Spravato 28 mg nasal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each nasal spray device contains esketamine hydrochloride
corresponding to 28 mg esketamine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution.
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Spravato,
in
combination
with
a
Selective
Serotonin
Reuptake
Inhibitor
(SSRI)
or
Serotonin-
Norepinephrine
Reuptake
Inhibitor
(SNRI),
is
indicated
for
adults
with
treatment-resistant
Major
Depressive Disorder, who have not responded to at least two different
treatments with antidepressants in
the current moderate to severe depressive episode.
Spravato is indicated, in conjunction with oral antidepressant
therapy, for the rapid reduction of depressive
symptoms in adult patients with Major Depressive Disorder who have
acute suicidal ideation or behavior.
The effectiveness of Spravato in preventing suicide or in reducing
suicidal ideation or behavior has not
been demonstrated. Use of Spravato does not preclude the need for
hospitalization if clinically warranted,
even if patients experience improvement after an initial dose of
Spravato.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The decision to prescribe Spravato should be determined by a
psychiatrist.
Spravato is intended to be self-administered by the patient under the
direct supervision of a healthcare
professional.
A treatment session consists of nasal administration of Spravato and a
post-administration observation
period. Both administration and post-administration observation of
Spravato should be carried out in an
appropriate clinical setting.
Assessment before treatment
Prior to dosing with Spravato blood pressure should be assessed.
DISETUJUI OLEH BPOM : 28 APRIL 2022
EREG10037412100049
If baseline blood pressure is elevated the risks of short-term
increases in blood pressure and benefit of
Spravato treatment should be considered (see section 4.4). Spravato
should not be a